Tumor Treating Fields With Chemoradiation in Newly Diagnosed GBM

NCT03705351 | Terminated Phase 1 Results DMC FDA Drug FDA Device

• 1 other identifier: UNITYGBM01
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief Summary

The study is an open-label pilot study in newly diagnosed glioblastoma patients following surgery. Eligible patients will receive treatment with tumor treating fields therapy using the Optune device starting less than 2 weeks prior to start of chemoradiation. Patients will receive radiation and temozolomide at a routine treatment dose and schedule.

Conditions

Glioblastoma; Cancer of Brain; Glioblastoma Multiforme; Brain Tumor

Keywords

temozolomide; tumor treating fields; optune; novocure; glioblastoma; brain tumor

Outcome Measures

Primary Outcomes (2)

• Rate of Treatment-Related Adverse Events Associated With Trimodal Therapy

  Number of patients who experienced a treatment-related adverse event

  15 Weeks (8 weeks after completion of trimodal therapy)

• Severity of Treatment-Related Adverse Events Associated With Trimodal Therapy

  Number of patients who experienced a treatment-related serious adverse event based on the NCI Common Terminology Criteria for Adverse Events (version 4.03)

  15 weeks (8 weeks after completion of trimodal therapy)

Secondary Outcomes (2)

• Overall Survival Rate

  Day 106

• Progression-free Survival at 6 Months and 24 Months

  6 months and 24 months

Study Arms (1)

Treatment

EXPERIMENTAL

Patients will receive trimodal therapy consisting of tumor treating fields therapy with the Optune device concurrent with temozolomide and radiation therapy.

Device: Tumor Treating Fields; Drug: Temozolomide; Radiation: Radiation Therapy

Interventions

Tumor Treating Fields DEVICE

Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM). Treatment will begin approximately 1 week prior to start of radiation and temozolomide treatment and continue concurrently throughout the duration of the study.

Also known as: Optune, Novocure

Treatment

Temozolomide DRUG

Patients will be given temozolomide according to routine treatment dosing and schedule.

Also known as: Temodar

Treatment

Radiation Therapy RADIATION

Patients will be given radiation therapy according to routine treatment dosing and schedule.

Treatment

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• GBM or Gliosarcoma by histology
• MGMT methylation status and IDH mutation status must be assessed at the study site or patient's referral center. MGMT status will be used for stratification purposes but will not exclude patients from this study if they are either methylated, unmethylated, or indeterminate, or in process at the time of enrollment. Similarly, subjects with tumors that are IDH mutated or wild type are both eligible.
• Supratentorial location
• Maximum safe resection (including patients who can only safely be biopsied)
• years of age or older
• Estimated survival of at least 12 weeks
• KPS 70% or greater at time of entry to study
• Patient provided written informed consent, or provided by a legally authorized representative
• Willingness to comply with all procedures, including visits or evaluations, imaging, laboratory tests and rescue measures
• Acceptable method of birth control (see appendix)
• Have had a contrast-enhanced brain MRI after tumor resection procedure. If biopsy alone performed, cranial CT may be used in place of MRI, only if the patient had a preoperative MRI scan within 14 days of the biopsy.
• The following time period must have elapsed prior to study enrollment: 3-6 weeks (21-42 days) from time of definitive surgery or 2-4 weeks (14-28 days) from the time of biopsy, for those who were only able to safely have a biopsy and not full resection.

You may not qualify if:

• Craniotomy or stereotactic biopsy wound dehiscence or infection
• Known by history to be HIV positive or to have an AIDS-related illness, active Hepatitis B, or active Hepatitis C (testing not required)
• Presence of skull defects (bullets, metal fragments, missing bone)
• Patients with implanted electronic medical devices (including but not limited to: pacemaker, vagal nerve stimulator, or pain stimulator)
• Prior invasive malignancy, unless disease free for 3 or more years, with the exception of basal cell carcinoma, cervical carcinoma in situ, or melanoma in situ
• Recurrent malignant gliomas or higher grade gliomas transformed from previous low grade (II) glioma
• Patients with any current Primary brain stem or spinal cord tumor
• Prior use of temozolomide
• Prior treatment with Avastin
• Individuals requiring \>8mg of dexamethasone per day within 7 days prior to Day 1 (high dose steroid taper following craniotomy with \>8mg of dexamethasone is allowed during the screening period, but subjects must taper down to 8mg or less of dexamethasone (or bioequivalent) within 7 days prior to Day 1).
• Clinically significant lab abnormalities at screening showing bone marrow, hepatic, and renal dysfunction:
• Thrombocytopenia (platelet count \< 100 x 103/μL)
• Neutropenia (absolute neutrophil count \< 1.5 x 103/μL)
• Significant liver function impairment - AST or ALT \> 3 times the upper limit of normal
• Total bilirubin \> upper limit of normal

Sponsors & Collaborators

• Providence Health & Services: lead
• University of California, San Francisco: collaborator
• NovoCure Ltd.: collaborator

Study Sites (2)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Related Links

• Providence Brain \& Spine Institute Clinical Research

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Interventions

Temozolomide; Radiotherapy

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Chiayi Chen / Director of PBSI and WC Clinical Research Program
• Organization: Providence Health & Services

Chiayi.Chen@providence.org

(503) 216-1012

Study Officials

• Ricky Chen, MD

  Providence Health and Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is an open-label pilot study. Following surgery, eligible patients will start tumor treating fields therapy with the Optune device less than 2 weeks prior to radiation and temozolomide given at a dose and schedule conforming to routine treatment.

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 15, 2018
• Study Start: December 2, 2019
• Primary Completion: February 24, 2021
• Study Completion: February 24, 2022
• Last Updated: March 4, 2024
• Results First Posted: March 4, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)